I am Just a Bill

Today is election day.  I wanted to talk about the process by which laws are passed and regulations created in healthcare.

Recently, the fall of the Chevron Doctrine has added an additional layer of complexity to regulatory interpretation, raising new questions about the future of healthcare regulation in the United States.

The legislative process begins in Congress, where bills are proposed by members of the House of Representatives or the Senate. Bills can be prompted by public needs, lobbying efforts from healthcare groups, or political initiatives. For instance, major pieces of healthcare legislation, like the Patient Protection and Affordable Card Act (ACA), are proposed as bills, debated in committees, and undergo a series of amendments before being voted on. If passed by both the House and Senate, the bill goes to the President, who can sign it into law or veto it. Upon becoming law, executive agencies are responsible for interpreting and implementing the statutes, which may involve drafting regulations.

Once a healthcare law is passed, regulatory agencies, such as the U.S. Department of Health and Human Services (HHS) or the Centers for Medicare & Medicaid Services (CMS), are tasked with drafting regulations that explain how the law will be applied in practice. This process begins with a Notice of Proposed Rulemaking (NPRM), where agencies publish proposed rules in the Federal Register, inviting comments from the public, stakeholders, and industry experts. The public comment period allows input from healthcare providers, insurance companies, advocacy groups, and individuals who may be impacted by the regulation.

After reviewing comments, the agency may revise the proposed rules and issue a final rule. This rule is then published in the Code of Federal Regulations (CFR), becoming binding. These rules clarify ambiguous language in legislation, set standards for compliance, and provide specifics that laws do not include. For example, CMS regulations under the ACA outline requirements for Medicaid expansion, insurance coverage standards, and reporting obligations.

Judicial review plays a significant role in shaping healthcare regulations. Courts may review regulations to ensure they do not exceed the authority granted by Congress or conflict with constitutional principles. The Chevron Doctrine, established by the Supreme Court in *Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc.* (1984), historically guided courts in reviewing agency interpretations of statutes. Under Chevron, courts would defer to an agency’s interpretation of an ambiguous statute, provided it was reasonable and not explicitly contradicted by Congress.

In healthcare, this meant that agencies like CMS had some flexibility in interpreting statutes under their purview. This deference allowed agencies to address complex, technical aspects of healthcare that require expertise beyond the judiciary’s scope.

The loss of Chevron deference may also lead to increased litigation as stakeholders challenge agency interpretations more frequently, believing that courts will more closely review agency decisions. This could slow the regulatory process and lead to greater uncertainty in healthcare compliance, especially as courts may lack the specialized knowledge required to make informed decisions on technical healthcare issues.

This new landscape may lead to slower and more litigious regulatory processes, impacting the ability of the healthcare system to adapt swiftly to changing needs and developments. The full implications of this shift are still unfolding, but it is clear that regulatory agencies will need to adjust their approaches to policy implementation, and healthcare stakeholders may need to prepare for a more uncertain regulatory environment.